Comparison of the Ability of the esCCO and the Volume View to Measure Trends in Cardiac Output During Cardiac Surgery

Sponsor
Université Libre de Bruxelles (Other)
Overall Status
Completed
CT.gov ID
NCT02964663
Collaborator
(none)
19
1
3.9
4.8

Study Details

Study Description

Brief Summary

The purpose of this study was to compare CO measured by two easy to use non-invasive monitors, the esCCO (Nihon Kohden, Tokyo, Japan) to the Volume View (Edwards Lifesciences, Irvine, USA) and to assess their trending ability in patients undergoing cardiac surgery.

Condition or Disease Intervention/Treatment Phase
  • Device: esCCO

Detailed Description

Cardiac output (CO) is a major physiological variable that should be monitored closely during cardiac surgery in order to assess and guide therapeutic interventions so as to decrease postoperative morbidity. The purpose of this study was to compare CO measured by two easy to use non-invasive monitors, the esCCO (Nihon Kohden, Tokyo, Japan) to the Volume View (Edwards Lifesciences, Irvine, USA) and to assess their trending ability in patients undergoing cardiac surgery. After Internal review board approval and written informed consent, 19 patients were included in this study. Before cardiopulmonary bypass (CPB), CO was measured simultaneously using both the esCCO and the Volume View device before and after 3 CO-modifying maneuvers [passive leg raise (PLR), end expiratory occlusion test (EEOT) and positive end expiratory pressure (PEEP) at 10 cm H2O. Five CO values for esCCO and three for volume view were averaged and compared during a one minute period of time before and after each maneuver. The precision error and its 95% confidence interval (CI) that corresponds to the least significant change (LSC) were calculated within this period of time. The Bland-Altman analysis was used to compare bias, precision and limits of agreement (LOA) of both devices. Trending ability of CO changes was assessed by a modified 4 quadrant plot analysis, within angular limits of agreement considered as acceptable when the mean angle between both delta CO was less than 30°.

Study Design

Study Type:
Observational
Actual Enrollment :
19 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparison of the Ability of the esCCO and the Volume View to Measure Trends in Cardiac Output During Cardiac Surgery
Study Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Mar 1, 2014
Actual Study Completion Date :
Mar 1, 2014

Outcome Measures

Primary Outcome Measures

  1. interchangeability of both devices (esCCO vs VV) [6 months]

    CO (L/min) was measured using esCCO and VV before and after 3 CO-modifying maneuvers (passive leg raise, PEEP of 10 cmH20, end expiratory occlusion test. Five CO values for esCCO and three for VV were averaged and compared during one minute period of time before and after each maneuver.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • patients scheduled for elective cardiac surgery
Exclusion Criteria:
  • age less than 18 years

  • known or potential pregnancy

  • arrhythmias

  • known significant tricuspid or aortic valve insufficiency

  • left or right ventricular dysfunction

  • peripheral arteriopathy

  • low perfusion index.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Erasme Hospital Brussels Belgium 1070

Sponsors and Collaborators

  • Université Libre de Bruxelles

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sarah Saxena, MD, Université Libre de Bruxelles
ClinicalTrials.gov Identifier:
NCT02964663
Other Study ID Numbers:
  • EsCCO vs VV
First Posted:
Nov 16, 2016
Last Update Posted:
Nov 16, 2016
Last Verified:
Nov 1, 2016
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 16, 2016